Claravis side effects: A detailed guide

This article describes possible side effects of Claravis. You can learn more about Claravis by talking with your doctor.

Claravis is a branded-generic medication that comes as a capsule that you swallow. Usually, generic drugs are referred to by the name of their active ingredient. But branded-generic drugs are given a proprietary name by the drugmaker. Claravis is available in a generic version called isotretinoin. This article describes possible side effects of Claravis.

Claravis has a boxed warning. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). For details, see the “Warnings for Claravis” section below.

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More common side effects of Claravis

Claravis may cause mild or serious side effects. Below are some of the more common side effects of this medication.

Commonly reported side effects of Claravis include:

• dry skin
• chapped lips
• dry eyes
• nosebleeds
• headache

Mild side effects of Claravis

Claravis may cause certain mild side effects. Usually, mild side effects are temporary and easily manageable. Tell your doctor or pharmacist if you have side effects that don’t go away or bother you.

Mild side effects of Claravis that occurred in studies include:

• weight loss
• dry skin
• chapped lips
• dry eyes
• nosebleeds
• headache
• fatigue
• dizziness
• hair loss
• back pain

Claravis may cause more mild side effects than those previously listed. For details, see the drug’s prescribing information.

Serious side effects of Claravis

Claravis may cause certain serious side effects. If you have any serious side effects from Claravis, call your doctor right away. But if you think you’re having a medical emergency or your side effects feel life threatening, take immediate action. Call 911 or a local emergency number, or go to the nearest emergency room.

After the Food and Drug Administration (FDA) approves a drug, it tracks and reviews side effects of the medication. Visit MedWatch’s website if you’d like to notify the FDA about a side effect you’ve had with Claravis.

Serious side effects of Claravis that occurred in studies include:

• serious skin reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN)
• pancreatitis, which can be life threatening in rare cases
• increased fat and cholesterol levels in your blood
• hearing problems, including hearing loss
• tinnitus (ringing in the ears)
• vision problems
• liver damage
• inflammatory bowel disease
• bone problems
• stroke
• decreased red and white blood cell levels
• increased blood sugar levels
• seizures
• mental health problems*
• brain problems*
• risk of serious problems with fetal development during pregnancy†

* To learn more about this side effect, see the “Side effects of Claravis in detail” section below.
† Claravis has a boxed warning for this side effect. A boxed warning is the most serious warning from the FDA. To learn more, see the “Warnings for Claravis” section below.

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Allergic reaction

For some people, Claravis can cause an allergic reaction.

In general, symptoms of allergic reaction can be mild or serious. You can learn more about possible symptoms in this article.

Ways to manage

For mild allergic reaction symptoms, such as a mild rash, call your doctor right away. They may recommend treatments to help manage your symptoms. They’ll also let you know whether you should keep taking the medication.

For severe allergic reaction symptoms, such as swelling or trouble breathing, call 911 or your local emergency number right away. These symptoms require immediate medical care because they can become life threatening. If you’ve had a serious allergic reaction to Claravis, your doctor may recommend taking a different medication instead.

Common questions about side effects of Claravis

Here are answers to some common questions about side effects of Claravis. If you have other questions, talk with your doctor or pharmacist.

Does taking a higher strength of Claravis, such as 30 or 40 milligrams (mg), increase the risk of side effects?

Possibly. Your risk of certain side effects may increase with higher strengths of Claravis. These include chapped lips and high triglyceride (fat) levels.

For this reason, it’s important to take Claravis exactly as prescribed by your doctor. Taking doses higher than recommended may increase your risk of side effects.

If you have concerns about your dosage of Claravis, talk with your doctor.

How do the side effects of Claravis vs. Accutane compare?

Claravis and Accutane both contain the active ingredient isotretinoin. (An active ingredient is what makes a drug work.) Accutane was one of the brand-name versions of isotretinoin, but it’s no longer available. Claravis is a branded-generic medication. Usually, generic drugs are referred to by the name of their active ingredient. But branded-generic drugs are given a proprietary name by the drugmaker.

Because both drugs contain the same active ingredient, they can cause the same side effects. For example, common side effects of both medications include dry skin, chapped lips, dry eyes, and dry nose. Both drugs also have a boxed warning for the risk of serious problems with fetal development during pregnancy. A boxed warning is the most serious warning from the FDA.

If you have more questions about how the side effects of Claravis and Accutane compare, talk with your doctor.

Does Claravis cause long-term side effects?

Yes, in some cases Claravis may cause long-term side effects. These can last for a while after you’ve stopped taking the drug.

Examples of long-term side effects reported with Claravis include:

• hearing loss
• vision changes, including vision loss and trouble seeing in the dark
• liver damage
• pancreatitis
• hair loss

Talk with your doctor to learn more about these side effects and how to manage them. Ask your doctor for more information about how long these side effects of Claravis may last.

Can Claravis cause weight loss?

Possibly. Weight loss was one of the side effects that occurred in studies of Claravis.

Weight loss may also be a sign of depression, which is another possible side effect of Claravis. (For more information, see the “Side effects of Claravis in detail” section that follows.

If you have concerns about your weight while taking Claravis, or if you have a change in your appetite or body weight, talk with your doctor right away.

Side effects of Claravis in detail

Here are details on some of the side effects of Claravis.

Mental health problems

Claravis can cause serious mental health problems, including depression, psychosis, and suicidal thoughts.

Symptoms of depression vary from person to person. But usually, it can make you feel a sense of hopelessness and lose interest in things that used to bring you joy. Other symptoms of depression may include lack of energy, feelings of loneliness or sadness, and thoughts of death and suicide.

With psychosis, your thoughts, feelings, and senses may not line up with reality. Symptoms may include hallucinations, personality changes, disorganized speech, or suicidal thoughts.

Ways to manage

If you experience symptoms of depression, psychosis, or have suicidal thoughts, stop taking Claravis and tell your doctor right away. They may recommend treatment from a mental health professional.

Suicide prevention

If you or someone you know is in crisis and considering suicide or self-harm, please seek support:

• Call the 988 Suicide and Crisis Lifeline at 988.
• Text HOME to the Crisis Text Line at 741741.
• Not in the United States? Find a helpline in your country with Befrienders Worldwide.
• Call 911 or your local emergency services number if you feel safe to do so.

If you’re calling on behalf of someone else, stay with them until help arrives. You may remove weapons or substances that can cause harm if you can do so safely.

If you are not in the same household, stay on the phone with them until help arrives.

Brain problems

In studies, brain problems occurred in people taking Claravis. This side effect may be serious.

Claravis can increase the pressure inside your brain. This can lead to permanent vision loss or even death. Other symptoms may include:

• severe headache
• blurry vision
• dizziness
• nausea or vomiting
• seizures
• stroke

Ways to manage

If you experience symptoms of brain problems, stop taking Claravis and tell your doctor right away. They’ll likely recommend taking a different medication.

Warnings for Claravis

Read on for some factors you may want to discuss with your doctor before taking Claravis.

Boxed warning

Claravis has a boxed warning. A boxed warning is the most serious warning from the FDA.

For details, see the “Claravis and pregnancy” section below.

Other warnings

It may not be safe for you to take Claravis if you have specific health conditions. These are sometimes called drug-condition interactions. Other factors may also affect whether Claravis is a safe treatment option for you.

Before taking Claravis, tell your doctor about your health and medications you take. Things to consider include:

• mental health conditions
• asthma
• liver problems
• diabetes
• heart disease
• osteoporosis or weak bones
• eating disorders
• past allergic reaction to Claravis

Claravis and pregnancy

Claravis has a boxed warning about certain risks if the drug is taken during pregnancy.

Boxed warning: Risk of serious problems with fetal development during pregnancy

Claravis has a boxed warning for the risk of serious problems with fetal development (also known as birth defects). A boxed warning is the most serious warning from the Food and Drug Administration (FDA).

You should not take Claravis during pregnancy because it can cause life threatening birth defects. This can occur even if it’s taken at low doses or for a short amount of time. Claravis can also cause pregnancy loss and premature births.

Due to this risk, Claravis is only prescribed through a special, restricted program called iPLEDGE. This program ensures that everyone who takes Claravis is aware of the serious risks it can cause if taken during pregnancy.

The iPLEDGE program requires people who can get pregnant to use two forms of birth control one month before, during, after treatment with Claravis. You’ll also have to take monthly pregnancy tests.

If you’re planning a pregnancy or can become pregnant, talk with your doctor before taking this medication. And if you get pregnant while taking Claravis, stop taking the drug and talk with your doctor right away.

Claravis and breastfeeding

You should not take Claravis while breastfeeding. If you’re currently breastfeeding or planning to do so, talk with your doctor before taking this medication. Your doctor may recommend other ways to feed your child during treatment with Claravis.

Claravis and alcohol

Claravis is not known to interact with alcohol.

However, drinking alcohol while taking Claravis can increase the risk of certain side effects. These include liver damage and increased fat and cholesterol levels in your blood.

If you drink alcohol, talk with your doctor about whether it’s safe to consume it during your treatment with Claravis.

Disclaimer: Optum Perks has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.